Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK3281 in Healthy and Hepatitis C Infected Male Patients - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00635804

Purpose

This study will examine the safety, tolerability and plasma pharmacokinetics of multiple doses of MK3281 in healthy male subjects in Part I, and in HCV-infected male patients in Part II. The clinical efficacy of MK3281, as measured by viral load reduction, will also be assessed in Part II. The results of this study will guide dose selection for future studies in both healthy subjects and HCV-infected patients.

Condition	Intervention	Phase
Hepatitis C	Drug: MK3281 Drug: Comparator: placebo (unspecified)	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 2-Part, Randomized, Double-Blind, Placebo-Controlled, Multiple-Rising Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK3281 in Healthy Male Subjects and Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK3281 in Hepatitis C Infected Male Patients

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis C

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

To evaluate the safety, tolerability, and Pharmacokinetics of MK3281 in both healthy and HCV-infected males. [ Time Frame: administered for 10 consecutive days to healthy adult male subjects and 7 consecutive days in HCV-infected male patients ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To identify a generally safe and well-tolerated dose in HCV-infected patients that mediates a viral load reduction. [ Time Frame: After multiple dose oral administration of MK3281 throughout the duration of the study. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	41
Study Start Date:	June 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Panel A: study medication (100 mg) + matching Pbo	Drug: MK3281 Part I, 4 serial panels (Panels A, B, C, and D) will be administered oral doses (ranging from 100 mg to 800 mg) of MK3281 twice daily for 10 consecutive days. In Part II, another panel, Panel E, consisting of HCV-infected patients be administered 800 mg oral doses of MK3281, or matching placebo, twice daily for 7 consecutive days. Drug: Comparator: placebo (unspecified) Part I, 4 serial panels (Panels A, B, C, and D) will be administered oral doses of matching placebo, twice daily for 10 consecutive days. In Part II, another panel, Panel E, consisting of HCV-infected patients be administered matching placebo, twice daily for 7 consecutive days.
B: Experimental Panel B: study medication (200 mg) + matching Pbo	Drug: MK3281 Part I, 4 serial panels (Panels A, B, C, and D) will be administered oral doses (ranging from 100 mg to 800 mg) of MK3281 twice daily for 10 consecutive days. In Part II, another panel, Panel E, consisting of HCV-infected patients be administered 800 mg oral doses of MK3281, or matching placebo, twice daily for 7 consecutive days. Drug: Comparator: placebo (unspecified) Part I, 4 serial panels (Panels A, B, C, and D) will be administered oral doses of matching placebo, twice daily for 10 consecutive days. In Part II, another panel, Panel E, consisting of HCV-infected patients be administered matching placebo, twice daily for 7 consecutive days.
C: Experimental Panel C: study medication (400 mg) + matching Pbo	Drug: MK3281 Part I, 4 serial panels (Panels A, B, C, and D) will be administered oral doses (ranging from 100 mg to 800 mg) of MK3281 twice daily for 10 consecutive days. In Part II, another panel, Panel E, consisting of HCV-infected patients be administered 800 mg oral doses of MK3281, or matching placebo, twice daily for 7 consecutive days. Drug: Comparator: placebo (unspecified) Part I, 4 serial panels (Panels A, B, C, and D) will be administered oral doses of matching placebo, twice daily for 10 consecutive days. In Part II, another panel, Panel E, consisting of HCV-infected patients be administered matching placebo, twice daily for 7 consecutive days.
D: Experimental Panel D: study medication (800 mg) + matching Pbo	Drug: MK3281 Part I, 4 serial panels (Panels A, B, C, and D) will be administered oral doses (ranging from 100 mg to 800 mg) of MK3281 twice daily for 10 consecutive days. In Part II, another panel, Panel E, consisting of HCV-infected patients be administered 800 mg oral doses of MK3281, or matching placebo, twice daily for 7 consecutive days. Drug: Comparator: placebo (unspecified) Part I, 4 serial panels (Panels A, B, C, and D) will be administered oral doses of matching placebo, twice daily for 10 consecutive days. In Part II, another panel, Panel E, consisting of HCV-infected patients be administered matching placebo, twice daily for 7 consecutive days.
E: Experimental Panel E: study medication (800 mg) + matching Pbo	Drug: MK3281 Part I, 4 serial panels (Panels A, B, C, and D) will be administered oral doses (ranging from 100 mg to 800 mg) of MK3281 twice daily for 10 consecutive days. In Part II, another panel, Panel E, consisting of HCV-infected patients be administered 800 mg oral doses of MK3281, or matching placebo, twice daily for 7 consecutive days. Drug: Comparator: placebo (unspecified) Part I, 4 serial panels (Panels A, B, C, and D) will be administered oral doses of matching placebo, twice daily for 10 consecutive days. In Part II, another panel, Panel E, consisting of HCV-infected patients be administered matching placebo, twice daily for 7 consecutive days.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subject is judged to be in good/stable health based on medical history, physical examination, vital signs, and laboratory safety tests performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug
Subject has no clinically significant abnormality on electrocardiogram (ECG) performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug
Subject has been a nonsmoker for at least 6 months, and/or Patient agrees to suspend all smoking while in attendance at the clinical research unit (CRU)
Subjects with female partner(s) of childbearing potential must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug

Exclusion Criteria:

Subject has a history of stroke, chronic seizures, or major neurological disorder
Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases
Subject has a history of neoplastic disease (including leukemia, lymphoma, malignant melanoma), or myeloproliferative disease, regardless of the time since treatment.
Subject has positive Hepatitis B surface antigen (or other evidence of active Hepatitis B infection) at the prescreening (study) visit
For Healthy Panel, subject has evidence of chronic Hepatitis C virus infection at the prescreening (study) visit
Subject has a history of documented HIVinfection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635804

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_507, MK3281-002
Study First Received:	February 28, 2008
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00635804 History of Changes
Health Authority:	Scotland: Scottish Executive Health Department

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases

Hepatitis, Viral, Human
Healthy
Hepatitis C

Additional relevant MeSH terms:

Virus Diseases
Hepatitis
RNA Virus Infections
Liver Diseases

Digestive System Diseases
Flaviviridae Infections
Hepatitis, Viral, Human
Hepatitis C

ClinicalTrials.gov processed this record on September 10, 2009